CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 23 enrolled
Drug / intervention
Lazandadrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02571634
NCT02571634Phase 4Completed
CompareCT.gov

Open Label Feasibility Pilot Study to Assess the Efficacy and Safety of the Use of Lazanda for Anxiolysis During Radiofrequency Nerve Ablation of Lumbar Facet Joints

Defense and Veterans Center for Integrative Pain Management·interventional·Posted Oct 8, 2015·Updated Oct 25, 2016

In Brief

A Phase 4 clinical trial evaluating Lazanda for Minor Procedural Pain. Completed, enrolled 23 participants across 1 site.

Detailed Summary

The purpose of this study is to evaluate the effectiveness, feasibility and safety of intranasal fentanyl (Lazanda) as an alternative to the current gold standard (diazepam) to produce anxiolysis and improve patient comfort during and after radiofrequency ablations of the lumbar facet joints. If this pilot study shows a positive effect and Lazanda is found to be feasible and safe for use during procedures, future larger scale studies can be done.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMinor Procedural Pain
CountriesUnited States
CollaboratorsDepomed

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedOct 8, 2015
Enrollment StartMay 1, 2015
Primary CompletionJan 1, 2016
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 10.7 years ago

Interventions

Lazandadrug

Given pre radiofrequency ablation of the lumbar facet joints to see if patients can remain alert, and it provides relaxation and pain control.